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    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
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    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFUSION KITS (WITH OR W/O PUMP), SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IV-S40009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.777Z</lastUpdated>
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    <udiDi>18586026080817</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH120810BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>18586026080824</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH121010BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.746Z</lastUpdated>
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    <udiDi>18586026080831</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH121210BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.732Z</lastUpdated>
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    <udiDi>18586026080848</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH121510BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.711Z</lastUpdated>
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    <udiDi>18586026080855</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH121710BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.687Z</lastUpdated>
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    <udiDi>18586026080862</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH122010BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.666Z</lastUpdated>
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    <udiDi>18586026080879</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH122310BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.647Z</lastUpdated>
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    <udiDi>18586026080886</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH122510BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.625Z</lastUpdated>
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    <udiDi>18586026080893</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH122710BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.611Z</lastUpdated>
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    <udiDi>18586026080909</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH123010BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.595Z</lastUpdated>
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    <udiDi>18586026080916</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH123510BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.581Z</lastUpdated>
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    <udiDi>18586026080923</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH124010BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.562Z</lastUpdated>
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    <udiDi>18586026080930</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH124510BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.549Z</lastUpdated>
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    <udiDi>18586026080947</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH125010BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.532Z</lastUpdated>
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    <udiDi>18586026080954</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH140810BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.520Z</lastUpdated>
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    <udiDi>18586026080961</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH141010BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.504Z</lastUpdated>
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    <udiDi>18586026080978</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH141210BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.482Z</lastUpdated>
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    <udiDi>18586026080985</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH141510BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.464Z</lastUpdated>
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    <udiDi>18586026080992</udiDi>
    <basicUdiDi>602147GBUTTON5G</basicUdiDi>
    <tradeName>Low-Profile Gastrostomy Replacement Tube (G. Button) Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GASTROSTOMY, TUBES AND SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GH141710BI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:54:14.441Z</lastUpdated>
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